Mitral valve prosthesis

ABSTRACT

A prosthetic device for treating a mitral valve includes a prosthetic insert member insertable between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to gap between leaflets of a mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. The insert member includes a valve that permits one-way blood flow therethrough. An anchoring member secures the prosthetic insert member to a heart wall.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/963,149, filed Dec. 8, 2015, now U.S. Pat. No. 9,579,199, which is acontinuation of U.S. patent application Ser. No. 14/636,011, filed Mar.2, 2015, which is a continuation of U.S. patent application Ser. No.13/439,336, filed Apr. 4, 2012, now U.S. Pat. No. 8,968,395, which is acontinuation of U.S. patent application Ser. No. 11/756,530, filed May31, 2007, which claims the benefit of U.S. Provisional PatentApplication No. 60/810,085, filed Jun. 1, 2006, the entire disclosuresof which are incorporated herein by reference in their entireties.

FIELD OF THE DISCLOSURE

The disclosure relates to the field of implantable cardiac prostheticsand in particular, to a cardiac prosthetic insert for reducingregurgitation through a heart valve, such as the aortic valve, and tomethods of implanting the cardiac prosthetic insert.

BACKGROUND

Heart valve regurgitation, or leakage from the outflow to the inflowside of a heart valve, is a condition that occurs when a heart valvefails to close properly. Heart valve regurgitation decreases theefficiency of the heart, reduces blood circulation and adds stress tothe heart. In early stages, heart valve regurgitation leaves a personfatigued and short of breath. If left unchecked, the problem can lead tocongestive heart failure, arrythmias or death.

Regurgitation through the aortic valve, sometimes referred to as aorticinsufficiency, is a serious problem that affects the health of millionsof adults. The aortic valve is positioned on the left side of the heartbetween the left ventricle and the aorta. A healthy aortic valve opensto allow blood to flow from the left ventricle into the aorta duringventricular systole and then closes to prevent blood from flowingbackward from the aorta into the left ventricle during ventriculardiastole. However, over time, changes in the geometric configurations ofthe aortic annulus, or other causes such as calcification, infection andinjury, may affect the functionality of the aortic valve. As a result,the aortic valve may not close completely during ventricular diastole,thereby leading to regurgitation.

Aortic insufficiency is typically treated by replacing the defectivenative valve with a prosthetic valve during open heart surgery. However,open-heart surgery is highly invasive and is therefore not an option formany high risk patients. Accordingly, in recent years, less invasivemethods, such as percutaneous valve replacement, have been developed forreplacing aortic valves. In an example, a prosthesis including a stentand a valve is crimped into a small profile and then delivered into theheart via a percutaneous route. Once located at the treatment site, theprosthesis is expanded to replace the function of the native aorticvalve. Although percutaneous valve replacement has shown great promise,there are still challenges with respect to delivery techniques,perivalvular leakage and durability of the valve. Furthermore, whenpossible, it may be desirable to repair, rather than replace, the nativevalve.

SUMMARY

Accordingly, disclosed herein is a device and method of use for treatingheart valve disease, involving in exemplary embodiments, a minimallyinvasive procedure that does not require extracorporeal circulation.Certain embodiments of such a device and method desirably are capable ofreducing or eliminating regurgitation through a heart valve. It is alsodesirable that embodiments of such a device and method be well-suitedfor delivery in a percutaneous or minimally-invasive procedure. It isalso desirable that embodiments of such a device and method bewell-suited for repairing an aortic valve. It is also desirable thatsuch a device be safe, reliable and easy to deliver. It is alsodesirable that embodiments of such a device and method be applicable forimproving heart valve function for a wide variety of heart valvedefects. It is also desirable that embodiments of such a device andmethod be capable of improving valve function without replacing thenative valve.

Various embodiments of the present disclosure provide improved devicesand methods for improving the function of a defective heart valve.Particular embodiments can be configured to be implanted in a heartusing a percutaneous or minimally invasive procedure whereinextracorporeal circulation is not required.

In one representative embodiment of the present disclosure, a prostheticdevice includes an anchoring member and an insert member configured fordeployment between the leaflets of a native valve, such as the aorticvalve. The insert member is desirably shaped to fill the gap(s) betweenthe leaflets for creating a tight seal during ventricular diastole andthereby minimizing or preventing regurgitation through the aortic valve.The insert member is desirably sized such that the native leafletsengage the surfaces of the insert member. When configured for use with atypical aortic valve, the insert member desirably includes three armsextending radially outward from a central region. Each of the arms isshaped for placement between adjacent leaflets of the aortic valve. Theanchoring member is provided for securing the insert member in itsdeployed position. In exemplary embodiments, the anchoring member takesthe form of a stent configured for deployment in the ascending aorta. Inone variation, the insert member can be configured (e.g., with two arms)for use with an aortic valve having only two leaflets. In anothervariation, the insert member can be configured for use in a pulmonaryvalve for treating pulmonary insufficiency.

In another representative embodiment of the present disclosure, aprosthetic device includes an anchoring member formed of a stent and aninsert member configured for deployment between the leaflets of a nativeaortic valve. The anchoring member desirably includes a valve member forproviding unidirectional flow. The anchoring member is desirablyconfigured for delivery into an ascending aorta. The stent is expanded,either by self-expansion or by balloon expansion, such that the stent isanchored in the aorta. After deployment, the valve member in the stentprevents or minimizes blood from flowing backward through the aorta. Theinsert member is delivered into the native aortic valve to improve thenative valve function. Accordingly, two separate valves (e.g., stentedvalve and native valve) work in tandem for preventing regurgitationthrough the aortic annulus. By deploying the insert member in the nativevalve, the native valve is allowed to function as it should and bloodenters the coronary arteries in a substantially natural manner. Thestented valve supplements the function of the native valve. If desired,the stented valve could be constructed to close before or after(desirably after) the native valve to further influence and improve thenative valve function and also to improve hemodynamics.

In a representative embodiment, a system and method are provided fortreating a defective heart valve. The system includes a prostheticdevice including an anchoring member and an insert member. The systemfurther includes a delivery catheter for delivering the prostheticdevice into the heart via a percutaneous approach. The delivery catheterdesirably includes an elongate sheath having a lumen sized to receivethe prosthetic device. In exemplary embodiments, the prosthetic deviceis held within the sheath in a collapsed configuration duringadvancement through the subject's vasculature. In one variation, thesheath is configured for retrograde advancement and may be configuredwith a deflectable end portion for facilitating navigation around theaortic arch. After reaching the treatment site, the sheath is movedproximally relative to the prosthetic device to eject the device fromthe sheath. The device is then allowed to expand such that the insertconforms to the gaps in the aortic valve and the anchoring memberengages the inner wall of the aorta.

In another representative embodiment of the present disclosure, aprosthetic device includes an anchoring member and an insert memberhaving three expandable arms configured for deployment between the gapsin an insufficient aortic valve. Each arm desirably includes anexpandable region that opens in a manner somewhat similar to a parachutefor preventing regurgitation. During ventricular systole, eachexpandable region collapses such that the flow of blood through theaortic valve is not impeded.

In a certain representative embodiment of the present disclosure, aprosthetic device includes an insert member configured for deploymentwithin an aortic valve and an anchoring member configured for securementwithin the left ventricle. An elongate body portion is provided forcoupling the insert member to the anchoring member. If one variation,the prosthetic device can be delivered in multiple stages. In a firststage, the anchoring member is delivered and is then allowed to growinto the heart wall. After sufficient in-growth has occurred, in asecond stage, the insert member is attached to the anchoring member.

In another representative embodiment of the present disclosure, aprosthetic device includes an anchoring member and an insert memberconfigured for deployment between anterior and posterior leaflets of amitral valve. The insert member is desirably shaped to fill the gapbetween native leaflets for preventing regurgitation through the mitralvalve. The insert member is sized such that the mitral valve leafletsengage the surfaces of the insert member to create a tight seal duringventricular systole. In a variation of this embodiment, one or morepassageways are provided through the insert member for allowing blood toflow through the device in one direction to further improve valvefunction.

The foregoing and other features will become more apparent from thefollowing detailed description of several embodiments, which proceedswith reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a cross-sectional view of a heart.

FIG. 2 is a perspective view of a prosthetic device including ananchoring member and an insert member configured for deployment betweenleaflets of a native aortic valve.

FIG. 3 is a cross-sectional view of an insert member with an outercoating of biocompatible material.

FIG. 4 is a cross-sectional view of the insert member of FIG. 2positioned in an aortic valve.

FIG. 5 is a partial cut-away view of the aorta illustrating theprosthetic device of FIG. 2 deployed within a subject to treat aorticinsufficiency.

FIG. 6 is a perspective view illustrating an embodiment of a prostheticdevice wherein the insert member is directly attached to the anchoringmember.

FIG. 7 is a cross-sectional view of the insert member of FIG. 6contained within a sheath in a contracted condition for delivery to atreatment site.

FIG. 8 illustrates the insert member of FIG. 6 after being ejected fromthe sheath and expanding into an expanded condition.

FIG. 9A is a perspective view of a prosthetic device including an insertmember for deployment in the aortic valve and an anchoring member withengagement members for securement to the left ventricle.

FIG. 9B is an exploded view of an exemplary embodiment of a plurality ofengagement members shown in an expanded state.

FIG. 9C is a perspective view of the plurality of engagement members ofFIG. 9B shown in a compressed state for delivery to the heart.

FIG. 10 is a variation of the embodiment shown in FIG. 9A wherein analternative anchoring member is provided.

FIG. 11 is a perspective view of a prosthetic device similar to theembodiment illustrated in FIG. 2 wherein the anchoring member includes astent and a valve member for deployment in the ascending aorta.

FIG. 12 is a perspective view of a prosthetic device similar to theembodiment illustrated in FIG. 2 in which the insert member is formedwith two arms.

FIG. 13 is a perspective view of a prosthetic device including ananchoring member and an insert member deployed in a heart for treatingan insufficient mitral valve.

FIG. 14 is a cross-sectional view of the insert member of FIG. 13.

FIG. 15 is a cross-sectional view illustrating an insert member formedwith a passageway and valve member for allowing blood to flow throughthe insert member in one direction.

DETAILED DESCRIPTION OF SEVERAL EMBODIMENTS I. Explanation of Terms

Unless otherwise noted, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. In order to facilitate reviewof the various embodiments of the disclosure, the following explanationof terms is provided:

The singular terms “a”, “an”, and “the” include plural referents unlesscontext clearly indicates otherwise. The term “or” refers to a singleelement of stated alternative elements or a combination of two or moreelements, unless context clearly indicates otherwise.

The term “includes” means “comprises.” For example, a device thatincludes or comprises A and B contains A and B, but may optionallycontain C or other components other than A and B. Moreover, a devicethat includes or comprises A or B may contain A or B or A and B, andoptionally one or more other components, such as C.

The term “proximal” refers to a portion of an instrument closer to anoperator, while “distal” refers to a portion of the instrument fartheraway from the operator.

The term “subject” refers to both human and other animal subjects. Incertain embodiments, the subject is a human or other mammal, such as aprimate, cat, dog, cow, horse, rodent, sheep, goat, or pig. In aparticular example, the subject is a human patient.

Although methods and materials similar or equivalent to those describedherein can be used in the practice or testing of the present disclosure,suitable methods and materials are described below. In case of conflict,the present specification, including terms, will control. In addition,the materials, methods, and examples are illustrative only and notintended to be limiting.

II. An Anatomical Overview of the Human Heart

With reference to FIG. 1, a cross-sectional view of a heart 1 isprovided. Blood flows through the superior vena cava 2 and the inferiorvena cava 4 into the right atrium 6 of the heart 1. The tricuspid valve8 controls blood flow between the right atrium 6 and the right ventricle15. The tricuspid valve 8 is closed when blood is pumped out from theright ventricle 15 to the lungs. Thereafter, the tricuspid valve 8 isopened to refill the right ventricle 15 with blood from the right atrium6. Free edges of leaflets of the tricuspid valve 8 are connected via thechordae tendinae 10 to the papillary muscles 12 in the right ventricle15 for controlling the movements of the tricuspid valve 8. Blood fromthe right ventricle 15 is pumped through the pulmonary valve 20 to thepulmonary artery 22, which branches into arteries leading to the lungs.

After exiting the lungs, the oxygenated blood flows through thepulmonary veins 28 and enters the left atrium 26 of the heart 1. Themitral valve 30 controls blood flow between the left atrium 26 and theleft ventricle 17. The mitral valve 30 is closed during ventricularsystole when blood is ejected from the left ventricle 17 into the aorta34. Thereafter, the mitral valve 30 is opened to refill the leftventricle 17 with blood from the left atrium 26. Free edges of leafletsof the mitral valve 30 are connected via the chordae tendinae 11 to thepapillary muscles 13 in the left ventricle for controlling the movementsof the mitral valve 30. Blood from the left ventricle 17 is pumpedthrough the aortic valve 32 into the aorta 34 which branches intoarteries leading to all parts of the body. The aortic valve 32 includesthree leaflets (also known as flaps or cusps) collectively denoted byreference numeral 36. Leaflets 36 open and close to control the flow ofblood into the aorta 34 from the left ventricle 17 of the heart as itbeats.

III. Prosthetic Device for Reducing Regurgitation Through a Heart Valve

The efficiency of the heart may be seriously impaired if any of theheart valves is not functioning properly. For example, heart valves maylose their ability to close properly due to dilation of an annulusaround the valve or a flaccid, prolapsed leaflet. The leaflets may alsohave shrunk due to disease, such as rheumatic disease, thereby leaving agap in the valve between the leaflets. The inability of the heart valveto close will cause blood to leak backwards (opposite to the normal flowof blood), commonly referred to as regurgitation, through the aorticvalve into the left ventricle. Regurgitation may seriously impair thefunction of the heart since more blood will have to be pumped throughthe regurgitating valve to maintain adequate circulation.

Embodiments of the present disclosure provide devices and methods forimproving the function of a defective heart valve, such as an aorticvalve. The devices and methods disclosed herein are desirably deliveredinto a subject's heart using percutaneous or minimally invasive surgicalmethods. Accordingly, desirable delivery methods described herein do notrequire extracorporeal circulation (e.g., blood from a subject'scirculation being routed outside the body to have a process applied toand then, returned of the subject's circulation). For example, in oneembodiment, a delivery catheter (or similar delivery device) is insertedthrough an incision in the chest wall and then through the cardiactissue (e.g., through the apex of the heart) into a chamber of thepatient's beating heart. The delivery catheter can allow a prostheticdevice to be delivered into the heart in a collapsed configuration andthen expanded within the heart for treating a defective heart valve.Because the desired delivery methods do not require extracorporealcirculation, complications are greatly reduced as compared withtraditional open-heart surgery.

FIG. 2 illustrates an example of a prosthetic device 100 which can beemployed to reduce or eliminate regurgitation through a heart valve,such as the aortic valve. The prosthetic device 100 includes an insertmember 102 and an anchoring member 110. The insert member 102 desirablyincludes a solid outer surface for contacting native valve leaflets,such as the native aortic valve leaflets. As used herein, a “solid”surface refers to a non-perforated surface that does not include anyopenings through which blood can pass. As illustrated in FIG. 2, theinsert member 102 includes a first extension portion, or arm, 104, asecond extension portion, or arm, 106 and a third extension portion, orarm, 108. The extension portions 104, 106, 108 desirably are equallyangularly-spaced about a central portion 112 of the insert member 102and extend radially outwardly therefrom. The prosthetic device 100 caninclude a plurality of spacers or connecting members 120 for mountingthe insert member 102 at a position spaced from the anchoring member110. As shown in FIG. 2, three such spacers or connecting members 120are provided in the illustrated embodiment for coupling the insertmember 102 to the anchoring member 110.

In the illustrated embodiment, the anchoring member 110 takes the formof a self-expanding or balloon-expandable stent having an open-frameconstruction as depicted in FIG. 2. The anchoring member can be made ofvarious suitable expandable and/or elastic materials, such as stainlesssteel, titanium, shape memory alloys, or other biocompatible metals. Inone example, the anchoring member 110 is self-expanding and formed ofshape memory alloys, such as nickel titanium (NiTi) shape memory alloys,as marketed, for example, under the trade name Nitinol. In anotherexample, the anchoring member 110 is balloon-expandable and formed ofstainless steel or other suitable materials.

In particular embodiments, the anchoring member 110 comprises a stenthaving a plurality of angularly-spaced axial struts, or support members,that extend axially (longitudinally) of the member. The anchoring member110 can also include a plurality of axially-spaced, circumferentialbands, or struts, attached to the axial struts. The circumferentialstruts are formed with multiple bends that allow the anchoring member110 to be compressed to a smaller diameter for delivery to animplantation site and expanded to its functional size for anchoring theinsert member 102 to the heart. The circumferential struts can include aplurality of linear strut members arranged in a zig-zag or saw-toothconfiguration defining bends between adjacent strut members. In otherexamples, one or more of the circumferential bands can have a curved orserpentine shape rather than a zig-zag shape. In variations, theanchoring member 110 may further include fixation or attachment members,such as barbs, staples, flanges, hooks, and the like along the exteriorof the anchoring member 110 for enhancing the ability of the anchoringmember 110 to anchor insert member within the aorta. Further details ofexemplary stents that can be employed in the embodiments disclosedherein are disclosed in U.S. Pat. Nos. 6,730,118, 6,767,362, and6,908,481, each of which is incorporated herein by reference in itsentirety.

Although the anchoring member is primarily described in the form of astent, it will be appreciated that a wide variety of anchoringmechanisms may be used while remaining within the scope of the presentdisclosure. For example, the anchoring member can be formed by one ormore retainers. In a particular example, the anchoring member can be aplurality of spaced-apart retainers that extend outwardly to contacttissue near or within the heart valve annulus. The retainers are sizedand configured to secure the body to the heart valve annulus. Forinstance, the one or more retainers can be circular bands formed ofpolyethylene, polypropylene, polycarbonate, nylon,polytetrafluoroethylene, polyurethane, stainless steel, Nitinol,titanium, polyimide, polyester, shape-memory material, or a mixturethereof. The one or more retainers can include protrusions, barbs,needles, hooks, and like engagement members for assisting with anchoringthe prosthetic device within the heart valve.

The insert member 102 is configured for insertion between the leafletsof an insufficient aortic valve so as to fill the gap between theleaflets. In one specific example, the insert member 102 exhibitssufficient rigidity to substantially maintain its deployed shape and isresilient and/or flexible enough to be compressed to a reduced diameterfor delivery in a delivery sheath. The insert member can be formed fromplastic, metal (e.g., shape memory metal) or other biocompatiblematerial suitable for implantation into a subject. In particularexamples, as illustrated in FIG. 3, the insert member 102 can include aninner support layer 127 and an outer layer or sheath 128. The outerlayer 128 can be formed of a biocompatible material, such as acloth-like or fabric material (natural or synthetic) or a biologicalmaterial, such as collagen or biological tissue material in order toprotect the native leaflets from damage (e.g., to inhibit abrasion thatcould occur in response to engagement and disengagement of theleaflets). For instance, smooth animal pericardium such as equine,bovine, porcine or other animal pericardial tissue which is compatiblewith the native leaflets may be included within the outer layer 128.Such tissue may be tanned or fixed by a suitable tanning environment orthe pericardium can be cross-linked with glutaraldehyde and heparinbonded by a detoxification process. In a certain example, the biologicaltissue material can be one of the NO-REACT® natural tissue productsexhibit improved biocompatibility and mitigate calcification andthrombus formation. The outer layer 128 can cover the entire outersurface of the inner layer 127 or selected portions of the outersurface, such as those portions that come into contact with the nativeleaflets.

In certain examples, the diameter of the insert member 102 is similar tothe diameter of the native aortic valve such that each of the extensionportions extends into a cusp between leaflets in the aortic valve. As aresult, the insert member 102 of the device 100 remains centered withinthe aortic valve after deployment. In certain examples, the diameter ofthe insert member is about 18 mm to about 26 mm, with about 22 mm beinga specific example. The diameter of the insert member 102 can beslightly smaller as compared to the diameter of the anchoring member110. This configuration allows the insert member to collapse orfold-down to a reduced diameter for delivery in a delivery sheath.Additionally, the length of the insert member can vary. For example, inone embodiment, the length of the insert member is approximately thesame size as the length of the anchoring member. In other examples, thelength of the insert member is greater or smaller than that of theanchoring member. In certain examples, the length of the insert memberis about 20 mm to about 30 mm, with about 25 mm being a specificexample.

As illustrated in FIG. 4, the cross-sectional profile of the insertmember 102 can be shaped such that the native leaflets 36 a, 36 b, 36 care capable of contacting the sides of the insert member 102 to create atight seal during ventricular diastole. For example, the three spacedapart extensions or arms 104, 106 and 108 extend radially outward from acentral region 112 of the insert member 102. In certain examples, thearms taper in width from the central portion to the outer ends of theextension portions. For example, each arm includes a first end 114 and asecond end 116. The first end 114 is of a greater width than the secondend 116. The arms each include a first side 122 and a second side 124,each of which side is configured for contact with a native leaflet. Theends 114, 116 and the sides 122, 124 can be configured with smooth edgesto minimize or eliminate hemolytic effects. Further, each of the arms isconfigured to fill a gap between adjacent leaflets of an aortic valve,thereby preventing regurgitation through the aortic valve. The contactsurfaces of the arms can exhibit sufficient compliancy and/orflexibility to allow the native leaflets to engage the insert member 102and create a tight seal without damaging the leaflets. For example, asdescribed above, each arm can include biocompatible material, such ascollagen or pericardial tissue to inhibit abrasion that could occur inresponse to engagement or coaptation of the arms with the nativeleaflets.

When used to treat an aortic valve, the cross-sectional profile of theinsert member can be minimized to limit resistance to blood flow fromthe left ventricle into the aorta when the aortic valve is fully open.Furthermore, one or both ends of the insert member may be tapered orrounded such that there are no flat surfaces facing perpendicular to theflow of blood. With respect to the illustrated embodiment, it will beappreciated that the prosthetic device is capable of minimizing orpreventing regurgitation without utilizing any moving parts. The devicecan therefore achieve greater durability as compared with alternativeheart valve repair and replacement techniques that utilize moving parts.

The insert member 102 can be configured with expandable structures, suchas moveable flaps, to further impede regurgitation through the aorticvalve. Each expandable structure can be configured to fill a gap betweenadjacent native valve leaflets. In one example, the movable flaps can beconfigured to open in a manner similar to that of a parachute to blockregurgitation of blood between the leaflets of the native aortic valve.During ventricular systole, the moveable flaps collapse to allow bloodto flow from the left ventricle, through the native aortic valve andinto the aorta in a substantially unimpeded manner. Additional detailsregarding an expandable insert member (e.g., valve portion) can be foundin Applicant's co-pending U.S. application Ser. No. 11/407,582 (U.S.Patent Publication No. 2006/0241745), filed on Apr. 19, 2006, which ishereby incorporated by reference in its entirety. Principles andfeatures of the expandable prosthetic devices described in the '582Application, which are configured for use with a mitral valve, are alsoapplicable to the devices described herein for use in the aortic valve.

As mentioned above and as illustrated in FIG. 2, the prosthetic device100 includes a plurality of spacers or connecting members 120. Eachconnecting member can be generally cylindrical in shape, although anyother suitable shape may be employed. In certain examples, the length ofeach connecting member is about 6 mm to about 14 mm, with about 10 mmbeing a specific example. Each connecting member preferably couples anarm of the insert member 102 to the anchoring member 110. The connectingmembers 120 can assist in stabilizing the insert member 102. Eachconnecting member desirably exhibits sufficient rigidity tosubstantially maintain the insert member in a fixed position relative tothe anchoring member. The connecting members can be formed of plastic,metal or other biocompatible material suitable for implantation into asubject. The connecting members 120 also minimize interference of theprosthetic device with blood flow to the coronary arteries by allowingthe anchoring member 110 to be positioned above the coronary ostia andthe insert member 102 positioned in the native aortic valve.

As best illustrated in FIG. 4, the native leaflets 36 a, 36 b, 36 c ofthe aortic valve 32 contact the insert member 102 during ventriculardiastole to create a tight seal. By allowing the aortic valve 32 tocreate a tight seal, regurgitation from the aorta into the leftventricle is minimized or prevented. During ventricular systole, thenative leaflets open as they do naturally to allow blood to be pumpedfrom the left ventricle into the aorta. As can be seen in FIG. 4, thecross-sectional area of the insert member 102 is relatively small ascompared with the flow area through the aortic annulus. Accordingly, inthe illustrated embodiment, the insert member 102 will not substantiallyimpede the flow of blood through the aortic valve during ventricularsystole.

With reference to FIG. 5, the prosthetic device 100 is illustrated afterdeployment within a subject. As illustrated in FIG. 5, the anchoringmember 110 is deployed in the aorta above the aortic valve, such asabove the ostia of the coronary arteries 38 such as to not interferewith the flow of blood through the coronary arteries. The insert member102 is deployed within the native aortic valve to improve the functionof the aortic valve. For example, the insert member 102 is positionedwithin the native aortic valve with each arm 104, 106 and 108 extendingbetween adjacent edges of two leaflets such that the leaflets of theaortic valve 32 coapt with the arms 104, 106 and 108. The connectingmembers 120 extend from the anchoring member 110 to the insert member102 for maintaining the insert member 102 in a substantially fixedposition. During ventricular diastole, the leaflets of the aortic valve32 close and press against the walls of the insert member to create atight seal. Although the native leaflets in an insufficient or defectiveaortic valve may not be able to close completely, the arms of the insertmember 102 fill the gaps such that little or no blood is allowed to passfrom the aorta back into the left ventricle.

As shown, the native aortic valve is not excised and continues tofunction in a substantially normal manner. As a result, over time, itmay be possible to remove the prosthetic device if the native valve isable to heal itself or if an alternative treatment is found.

With reference to FIG. 6, a prosthetic device 200 according to anotherembodiment is shown. Prosthetic device 200 includes an insert member 102and an anchoring member 110. The insert member 102 in the illustratedembodiment is directly coupled to the anchoring member 110 rather thanvia the connecting members 120. For example, the insert member can becoupled to the anchoring member 110 via the proximal end 118 of theinsert member 102, for example with the proximal end of the insertmember 102 received partially within and surrounded by an end portion ofthe anchoring member 110. The diameter of the insert member 102 in theillustrated embodiment is less than the diameter of the anchoring member110. This configuration allows the insert member 102 to be collapsed orfolded during implantation, and then deployed within the valve.

The disclosed prosthetic devices can be configured to be delivered in apercutaneous or minimally invasive procedure in which only a smallaccess incision is required. In one example, the prosthetic device canbe configured so that it can be crimped or otherwise collapsed into asmaller profile and then placed in a delivery sheath for advancement tothe treatment site. FIG. 7, for example, illustrates a prosthetic device200 in a collapsed condition within a sheath 142. As shown, the insertmember 102 can be configured to be sufficiently flexible such that thearms can be folded or caused to assume a curved profile to temporarilyreduce the profile of the insert during delivery. After being ejectedfrom the sheath 142, the anchoring member 110 and insert member 102expand to a fully expanded condition as shown in FIG. 8. When deliveredto the aortic valve in a percutaneous procedure, it may be desirable toutilize a deflectable sheath to facilitate navigation through thepatient's vasculature and around the aortic arch. Details regardingvarious embodiments of a deflectable sheath configured to deliver atherapy device to an aortic valve can be found in Applicant's co-pendingU.S. application Ser. No. 11/152,288, filed Jun. 13, 2005, entitled“Heart Valve Delivery System,” which is hereby incorporated by referencein its entirety.

FIG. 9A illustrates a prosthetic device 300 that can be used to reduceor eliminate heart valve regurgitation, such as aortic valveregurgitation. In this embodiment, the prosthetic device includes aninsert member 102 configured for insertion into the aortic valve and ananchoring member 302 configured for securement to the muscular wall inthe left ventricle. The anchoring member 302 can include a plurality ofengagement members 304, such as hooks or fingers, that penetrate tissuealong the muscular wall for securing the insert member 102 to the heart.The engagement members 304 can be formed of any biocompatible material,such as biocompatible metals or plastics, which is capable ofpenetrating the left ventricle muscular wall to secure the insert member102 to the heart without substantially impairing the wall. The anchoringmember 302 can include an elongate body portion, or shaft, 306 whichcouples the engagement members 304 to the insert member 102. In oneexample, the elongate body portion 306 and the engagement members 304can be formed from a single piece of material. In another example, theelongate body portion 306 and the engagement members 304 can beseparately formed and subsequently coupled to one another by anysuitable means, such as welding. The elongate body portion 306 and theengagement members 304 can be formed of the same or different materialsdepending on the material properties (elasticity, rigidity, resilienceand the like) desired for each part of the device 300.

The prosthetic device 300 can be positioned within the heart to minimizeaortic valve regurgitation by positioning the plurality of engagementmembers 304 in the left ventricle near the left ventricular apex. In theillustrated embodiment, a plurality of fingers or hooks penetratestissue along the left ventricle muscular wall near the left ventricularapex. The insert member 102 is positioned in the aortic valve annulussuch that an upper portion and lower portion extend above and below thenative aortic valve and the arms of the insert member 102 are alignedwith coaptions of the three cusps of aortic valve so each leaflet movesup and down between the insert arms.

FIGS. 9B and 9C illustrate the lower end portion of an anchor member 302with a plurality of engagement members 304 in the form of elongatedprongs. The elongated prongs 304 are desirably configured to self-expandfrom the compressed configuration of FIG. 9C to a “flowered” or expandedconfiguration of FIG. 9B when advanced out of a delivery sheath. Thisflowering is desirably achieved with a self curving area 304 a thatdeflects the prongs 304 radially outward from the center of the body 502and rearward toward the second end of the body. The prongs 304 aredesirably pointed or barbed to facilitate penetration and engagementwith the muscular wall of the heart.

The anchor member 302 can be formed from a single tube of shape memorymaterial, such as, for example, Nitinol. During manufacture, the shapememory material may be cut using a mechanical or laser cutting tool.After cutting the tube, the expanded or flowered shape can be impartedto the memory of the shape memory material with techniques known in theart (e.g. heat setting the shape). Methods for manufacturing the anchormember are described in detail in Applicant's co-pending U.S.application Ser. No. 11/750,272 (hereinafter “the '272 application”),which is incorporated herein by reference. In one preferred embodiment,the anchor member is formed to have an expanded configuration thatconforms to the contours of the particular surface area of the heartwhere the anchor member is to be deployed, as described in the '272application.

The surface of the anchor member 302, including the prongs 304, isdesirably configured to promote tissue growth onto and even into itssurface. In one example this growth is achieved by providing the anchormember with a relatively rough and/or porous surface. Additionally,biological coatings of the types known in the art can be included on thesurface of the anchor member 302 to promote healing and tissue growth.

FIG. 10 illustrates another variation of an anchoring member 402 whereinone or more anchors, such as the illustrated plates 404, are located onopposite sides of the muscular wall of the heart for anchoring theprosthetic device 400 to the heart. The plates 404 can be formed of anybiocompatible material, such as biocompatible metals or plastics. Theanchoring member 402 includes a shaft 406 having an upper end portionconnected to the insert member 102 and a lower-end portion that extendsthrough the wall of the heart. One plate 404 is disposed on the shaftinside the left ventricle and another plate 404 is disposed on the shaftoutside the left ventricle to secure the shaft in place.

If desired, the prosthetic device may be deployed in multiple stageswherein, in a first stage, the anchoring member is attached to the aorta(or ventricular wall) before the insert member is delivered. In a secondstage, the insert member of the device is connected to the anchoringmember at a later time (e.g., hours, days or weeks later). The timebetween the first and second stages advantageously allows tissue to healand even grow over the anchoring member, thereby further embedding theanchoring member in the heart. Without the added stress that the insertmember of the device may impart on the tissue, the healing andover-growth may proceed more rapidly with less adverse affects (e.g.,unwanted scarring). Additional details regarding exemplary anchoringmembers, expandable insert members and two-stage deployment can be foundin the '272 application.

FIG. 11 shows another alternative embodiment of a prosthetic device,indicated at 500. The anchoring member 110 can be a stent and caninclude a valve member 130 mounted inside the stent. In the illustratedembodiment, the valve member 130 is a three-leaflet bioprosthetic valve.In particular examples, the anchoring member and valve member may takethe form of the Cribier-Edwards valve manufactured by EdwardsLifesciences of Irvine, Calif. Additional details regarding exemplaryembodiments of a stented valve can be found in U.S. Pat. No. 6,893,460,which is hereby incorporated by reference in its entirety.

The valve member 130 in the stent ensures unidirectional flow throughthe stent. The stent is desirably configured for delivery into anascending aorta. The stent is expanded, either by self-expansion or byballoon expansion, such that the stent is anchored in the aorta. Afterdeployment, the valve member in the stent prevents blood from flowingbackward through the aorta. The insert member is delivered into thenative aortic valve to improve the native valve function. Accordingly,two separate valves (i.e., the stented valve and the native valve) workin tandem for inhibiting regurgitation through the aortic annulus. Bydeploying the insert member in the native valve, the native valve isallowed to function as it should and blood is allowed to flow into thecoronary arteries in a substantially natural manner. The stented valvesupplements the function of the native valve. If desired, the stentedvalve could be constructed to close before or after the native valve tofurther influence and improve the native valve function and also toimprove hemodynamics and/or perfusion into the coronary arteries.

With reference to FIG. 12, a prosthetic device 600 according to yetanother embodiment is provided. The prosthetic device 600 is configuredfor use in an abnormal aortic valve having only two leaflets. To treatthis portion of the population, an insert member 602 is provided withtwo arms 604, 606 for filling the gaps between the leaflets. Inaddition, in certain aortic valves having three leaflets, it may not benecessary to fill gaps between each of the three leaflets. Accordingly,it may be desirable to use an insert member of the type shown in FIG. 12for preventing or reducing regurgitation in a three leaflet valve.

For purposes of illustration, desirable embodiments of a prostheticdevice have been described above for use in a valve normally havingthree leaflets, such as an aortic valve. However, it will be recognizedby those of ordinary skill in the art that variations of the devices mayalso be used to treat another valve with three leaflets, such as apulmonary valve, in an analogous manner. When used to treat thepulmonary valve, the anchoring member (e.g., stent) can be configuredfor deployment in the pulmonary trunk or a pulmonary artery.Alternatively, the anchoring member may be secured within the rightventricle.

With reference now to FIGS. 13 through 15, a prosthetic device 700 isconfigured for treating a bicuspid valve, such as a defective mitralvalve. As illustrated in FIG. 13, the prosthetic device 700 includes aninsert member 702 and an anchoring member 704. The insert member 702comprises a body sized and shaped to fill the gap between the anteriorand posterior leaflets of an insufficient mitral valve.

In one specific example, the insert member 102 exhibits sufficientrigidity to substantially maintain its deployed shape and is resilientand/or flexible enough to be compressed to a reduced diameter fordelivery in a delivery sheath. The insert member can be formed fromplastic, metal or other biocompatible material suitable for implantationinto a subject. In particular examples, as described previously, theinsert member can include an outer layer or sheath substantially formedof a biocompatible material, such as a cloth-like or fabric material(natural or synthetic) or a biological material, such as collagen orbiological tissue material in order to protect the native leaflets fromdamage (e.g., to inhibit abrasion that could occur in response toengagement and disengagement of the leaflets). For instance, smoothanimal pericardium such as equine, bovine, porcine or other animalpericardial tissue which is compatible with the native leaflets may beincluded within the outer layer. Such tissue may be tanned or fixed by asuitable tanning environment or the pericardium can be cross-linked withglutaraldehyde and heparin bonded by a detoxification process. In acertain example, the biological tissue material can be one of theNO-REACT® natural tissue products exhibit improved biocompatibility andmitigate calcification and thrombus formation. The outer layer can coverthe entire outer surface of the insert member 102 or selected portionsof the outer surface, such as those portions that come into contact withthe native leaflets. The insert member 702 can be shaped with taperedand/or smooth edges to minimize or eliminate hemolytic effects.

The cross-sectional profile of the insert member 702 is shaped such thatthe native leaflets are capable of contacting the sides 703 a and 703 bof the insert member 702 to create a tight seal. As illustrated in FIGS.13-15, the insert member 702 preferably has a crescent-shapecross-sectional profile to better conform to the curvature of the nativeleaflets. The surface of the insert member 702 can be of a compliancythat allows the native leaflets to engage the insert member 702 tocreate a tight seal without damaging the leaflets. For example, asdescribed above, the surface can comprise a biocompatible material, suchas collagen or pericardial tissue to inhibit abrasion that could occurin response to engagement or coaptation of the insert member surfacewith the native leaflets. In operation, the native leaflets of themitral valve press against the walls of the insert member duringventricular systole to create a tight seal and prevent regurgitation ofblood from the left ventricle into the left atrium.

In the illustrated embodiment, the anchoring member 704 of theprosthetic device 700 includes a shaft or elongated body portion 706,the lower end portion of which forms a penetration member 708. Plates709 can be disposed on the penetration member 708 on opposite sides ofthe heart wall to secure the shaft in place. The body portion 706 andpenetration member 708 of the anchoring member 704 may be of anysuitable shape and material that imparts the material properties(elasticity, rigidity, resilience and the like) desired for each part ofthe device 700. For example, the penetration member 708 can be formed ofany biocompatible material, such as biocompatible metals or plastics,which is capable of penetrating the left ventricle muscular wall tosecure the insert member 702 to the heart without substantiallyimpairing the wall.

In one example, the anchoring member 704 may be configured fordeployment in the left ventricle. FIG. 14 is a cross-sectional view ofthe insert member 702 shown in FIG. 13. In this embodiment, the insertmember 702 can have a substantially solid cross-section. In a variation,as shown in FIG. 15, the insert member 702 may include a passagewayextending along a longitudinal axis. The passageway can be adapted toallow blood to flow through the insert member in one direction. A valvemember can be included within the insert to ensure that blood flows inonly one direction. In a particular example, the valve member cancomprise one or more flap members 712 defining a slit or opening 710.The valve member mimics the function of the target valve by allowingblood flow in only one direction. Thus, blood flow passing into thepassage from one direction opens the flaps and thereby passes throughthe insert member while blood moving into the passage from the oppositedirection is stopped by the valve.

IV. System and Methods for Reducing Regurgitation Through a Heart Valve

Disclosed herein are a system and methods for treating a defective heartvalve. In one embodiment, the system includes a prosthetic deviceincluding an anchoring member, such as a self-expandable anchoringmember, and an insert member. The system can further include a deliverycatheter for delivering the prosthetic device into the heart via apercutaneous approach. For example, the catheter can be introducedpercutaneously into the patient's vasculature (e.g., into a peripheralartery such as the femoral artery) and advanced to the implantationsite. In certain embodiments, for example, the catheter is sized forinsertion through a small incision in the groin and has a length of atleast about 80 cm, usually about 90-100 cm, to allow transluminalpositioning of the shaft from the femoral and iliac arteries to theascending aorta in a retrograde approach. Alternatively, the cathetermay have a shorter length, e.g. about 20-60 cm, for introduction throughother insertion points, such as, for example, the iliac artery, thebrachial artery, the carotid or the subclavian arteries. In the femoralapproach, the catheter desirably is long enough and flexible enough totraverse the path through the femoral artery, iliac artery, descendingaorta and aortic arch. At the same time, the catheter desirably hassufficient pushability to be advanced to the ascending aorta by pushingon the proximal end, and has sufficient axial, bending, and torsionalstiffness to allow the physician to control the position of the distalend, even when the catheter is in a tortuous vascular structure.Alternatively, the catheter may be passed through a port between ribs.In one technique, the catheter is advanced through the patient's thoraxabove the heart and through an incision in the aortic arch, in aso-called minimally-invasive procedure. In another technique, thecatheter is advanced through an incision in the heart wall, preferablyalong the apex of the heart. The prosthetic device is advanced to theheart valve that is to be treated, and it is positioned to extend acrossthe valve with the arms of the device interposed between the leafletssuch that the leaflets of the valve close and press against the walls ofthe insert member to create a tight seal.

In certain embodiments, the delivery catheter includes an elongatedsheath having a lumen sized to receive the prosthetic device. Theprosthetic device is held within the sheath in a collapsed configurationduring advancement through the subject's vasculature. For example,during advancement to the left ventricle, the device is initiallycontained within the delivery sheath with the anchoring member retainedin a radially compressed state. In one variation, the distal portion ofthe delivery sheath is configured for retrograde advancement and may beconfigured with a deflectable end portion for facilitating navigationaround the aortic arch. After reaching the treatment site, the sheath ismoved proximally relative to the prosthetic device to eject the devicefrom the sheath. The device is then allowed to expand such that theinsert conforms to the gaps in the aortic valve and the anchoring memberengages the inner wall of the aorta.

Although embodiments of the present invention are preferably configuredfor percutaneous or minimally-invasive delivery procedures, in certainsituations, the insert member may be deployed via an open-heart surgicalprocedure. In these embodiments, a delivery catheter may not benecessary since the defective native valve can be directly accessed.

Although the disclosure has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the disclosure and should not be construed to limit thescope thereof.

What is claimed is:
 1. A prosthetic device for a mitral valvecomprising: a longitudinal axis; an insert member including an innersupport layer and an outer layer, the inner support layer comprising ashape-memory metal, the outer layer comprising fabric, an inflow end,and an outflow end, the longitudinal axis passing through the inflow endand the outflow end, a passageway extending through the insert memberalong the longitudinal axis, and a one-way valve disposed within thepassageway, the one-way valve including one or more flaps, the one-wayvalve permitting blood flow from the inflow end to outflow end, whereinthe insert member in the compressed state has a diameter suitable fordelivery in a delivery sheath, the insert member has an expanded stateand a compressed state, the insert member in the expanded state has across-sectional profile transverse to the longitudinal axis in whichsides of the insert member are shaped for creating a tight seal againstnative mitral valve leaflets, the insert member in the expanded statesufficiently rigid to substantially maintain a shape thereof; and ananchoring member extending longitudinally from the insert member, theanchoring member including a proximal end portion and a distal endportion, the proximal end portion coupled to the insert member, thedistal end portion of the anchoring member including a self-expanding,flower-shaped anchor having a compressed configuration and an expandedconfiguration, the flower-shaped anchor suitable for anchoring to a leftventricular wall.
 2. The prosthetic device of claim 1, wherein theflower-shaped anchor includes a plurality of elongated prongs.
 3. Asystem comprising the prosthetic device of claim 1 and a deliverycatheter, the prosthetic device with the insert member in the compressedstate receivable in a lumen of the delivery catheter.
 4. A prostheticdevice for a mitral valve comprising: a longitudinal axis; an insertmember including an inner support layer and an outer layer, the innersupport layer comprising a shape-memory metal, the outer layercomprising fabric, an inflow end, and an outflow end, the longitudinalaxis passing through the inflow end and the outflow end, a passagewayextending through the insert member along the longitudinal axis, and aone-way valve disposed within the passageway, the one-way valveincluding one or more flaps, the one-way valve permitting blood flowfrom the inflow end to outflow end, wherein the insert member in thecompressed state has a diameter suitable for delivery in a deliverysheath, the insert member has an expanded state and a compressed state,the insert member in the expanded state has a cross-sectional profiletransverse to the longitudinal axis in which sides of the insert memberare shaped for creating a tight seal against native mitral valveleaflets, the insert member in the expanded state sufficiently rigid tosubstantially maintain a shape thereof; and an anchoring memberextending longitudinally from the insert member, the anchoring memberincluding a proximal end portion and a distal end portion, the proximalend portion coupled to the insert member, the distal end portion of theanchoring member comprising a penetration member including an elongatedbody portion suitable for penetrating through the left ventricular wall.5. The prosthetic device of claim 4, wherein the anchoring memberfurther comprises at least one plate, the at least one plate engageablewith the penetration member for securing the penetration member to theheart.
 6. A system comprising the prosthetic device of claim 4 and adelivery catheter, the prosthetic device with the insert member in thecompressed state receivable in a lumen of the delivery catheter.
 7. Aprosthetic device for a mitral valve comprising: a longitudinal axis; aninsert member including an inner support layer and an outer layer, theinner support layer comprising metal, the outer layer comprising fabricor biological material, an inflow end, and an outflow end, thelongitudinal axis passing through the inflow end and the outflow end, apassageway extending through the insert member along the longitudinalaxis, and a one-way valve disposed within the passageway, the one-wayvalve including one or more flaps, the one-way valve permitting bloodflow from the inflow end to outflow end, wherein the insert member inthe compressed state has a diameter suitable for delivery in a deliverysheath, the insert member has an expanded state and a compressed state,the insert member in the expanded state has a cross-sectional profiletransverse to the longitudinal axis in which sides of the insert memberare shaped for creating a tight seal against native mitral valveleaflets, the insert member in the expanded state sufficiently rigid tosubstantially maintain a shape thereof; and an anchoring memberextending longitudinally from the insert member, the anchoring memberincluding a proximal end portion and a distal end portion, the proximalend portion coupled to the insert member, the distal end portion of theanchoring member suitable for anchoring to a left ventricular wall. 8.The prosthetic device of claim 7, wherein the insert member comprises ashape memory metal.
 9. The prosthetic device of claim 7, wherein thecross-sectional profile of the insert member has a crescent shape. 10.The prosthetic device of claim 7, wherein the outer layer is disposedover selected portions of an outer surface of the inner layer.
 11. Theprosthetic device of claim 7, wherein the distal end portion of theanchoring member comprises a self-expanding, flower-shaped anchor havinga compressed configuration and an expanded configuration.
 12. Theprosthetic device of claim 11, wherein the flower-shaped anchor includesa plurality of elongated prongs.
 13. The prosthetic device of claim 11,wherein each prong comprises a self-curving area that deflects theprongs radially outward from a center of the body and towards theproximal end of the anchor member.
 14. The prosthetic device of claim11, wherein the self-expanding anchor comprises nitinol.
 15. Theprosthetic device of claim 7, wherein the distal end portion of theanchoring member comprises a penetration member including an elongatedbody portion suitable for penetrating through the left ventricular wall.16. The prosthetic device of claim 15, wherein the anchoring memberfurther comprises at least one plate, the at least one plate engageablewith the penetration member for securing the penetration member to theheart.
 17. The prosthetic device of claim 15, wherein penetration membercomprises a biocompatible metal or a biocompatible plastic.
 18. A systemcomprising the prosthetic device of claim 7 and a delivery catheter, theprosthetic device with the insert member in the compressed statereceivable in a lumen of the delivery catheter.
 19. The system of claim18, wherein the catheter is dimensioned for insertion at a femoralartery or an iliac artery.
 20. The system of claim 18, wherein thecatheter is dimensioned for insertion at an apex of the heart.